The Mechanism of Action of Chlormethine (CL) Gel in the Treatment of MF-CTCL Adult Patients

Launched by NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Chlormethine (CL) gel for patients with Mycosis Fungoides, a type of skin lymphoma. Chlormethine has been used for many years and is known to be effective, but some patients have experienced skin reactions that can limit its use. The researchers want to learn more about how this gel works and how it affects different types of skin cells in patients with early or late-stage Mycosis Fungoides who have not previously used Chlormethine gel.

To participate in this trial, patients need to be at least 18 years old and must have a diagnosis of early-stage Mycosis Fungoides or late-stage patients who are not currently experiencing active tumors. They should not have received Chlormethine gel treatment before and must meet specific health criteria. Participants will apply the gel as directed and will be monitored throughout the study. It's important for women who could become pregnant to have a negative pregnancy test and use effective birth control during the trial. Overall, this study aims to ensure that Chlormethine gel is both safe and effective for treating this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • MF-CTCL early-stage diagnosed patients, or late-stage patients that relapse without current active tumoral disease who still have patches and/or plaques.
• • Age ≥ 18 years
• • Patients naïve from CL gel treatment
• • Early-stage patients who will be using CL as monotherapy: at enrolment without any concomitant MF treatment
• • Early-stage patients if treated with other topical or systemic (late or early-stage patients) at enrolment, then a 2 week for topical steroids (and/or other topical treatment) and 4 weeks for systemic treatments wash out period will be required
• • Women of child bearing potential must have a negative serum pregnancy test within 3 days prior enrolment.
• • Women of child bearing potential should use adequate birth control measures, during the study treatment period until 30 days after treatment
• • Women who are breast feeding should discontinue nursing prior to the first application of study treatment and until 30 days after the last study treatment
• • Before patient enrolment, written informed consent must be given according to ICH/GCP
• Exclusion Criteria:
• • - Patients diagnosed with stage III and IV, unless they meet the inclusion criteria for late stage disease (see above)
• • Patients with multiple active tumors - progressive disease
• • Patients with concomitant and chronic use of topical or systemic corticosteroids for the treatment of any other disease
• • Patients treated with concomitant topical (except chlormethine gel) and/or systemic MF treatments who have missed the wash-out period (2 weeks for topical treatment and 4 weeks for systemic treatment)
• • Acute flare or atopic dermatitis or other dermatosis in the last 3 weeks
• • Pregnant and breast-feeding women
• • Patients unable to comply with study procedures (e.g. provide written consent, fill in the questionnaires, geographical condition potentially hampering compliance with the study protocol and follow-up schedule).
• • Known hypersensitivity to any component of the CL gel formulation
• • Concurrent or planned local or systemic anti-CTCL therapies